FDA.reportPublic FDA data

AIRSEP CORP.

Matched from indexed company URL: AIRS, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
13190443006277965AIRSEP CORP.1N2026-01-01260 Creekside Dr Buffalo NY US 14228
22498013003238169AirScan, Inc.1N2026-01-0167 Beaver Ave Annandale NJ US 08801
30061041913006104191AirStrip Technologies, Inc.1N2026-01-012915 W Bitters Rd. Suite 215 SAN ANTONIO TX US 78248
30248201863024820186AIRS Medical Inc.1N2026-01-0113-14F, Keungil Tower 223, Teheran-ro, Gangnam-gu Seoul KR 06142

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B15320030AirStrip ONE Web Client - Medical Device Software Application1-877-258-5869support@airstrip.com
B153300010AirStrip ONE Platform - AirStrip Cardiology, Patient Monitoring, OB - Server Platform1-877-258-5869supportcenter@airstrip.com
B153301010AirStrip ONE Client iOS - AirStrip Cardiology, Patient Monitoring and OB - Client iOS1-877-258-5869supportcenter@airstrip.com
B153301020AirStrip ONE Client Android - AirStrip Cardiology, Patient Monitoring, OB - Client Android1-877-258-5869supportcenter@airstrip.com
B153301030AirStrip ONE Client Web - AirStrip Patient Monitoring - Client Web1-877-258-5869supportcenter@airstrip.com
B153500010AirStrip Alarm Management - AirStrip ONE Web Client with Alarm Communication Management (ACM) - AirStrip Alarm Management (AAM)1-877-258-5869supportcenter@airstrip.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
192971514339982K991876SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATEJPK1999-06-17
192971440523780K884623SAFE-TEC CAPILLARY BLOOD COLLECTION TUBEGIO1988-12-01
3105001397472526K253775SwiftMRQIH2026-03-26
3105001889734827K251483SwiftSight-BrainQIH2025-09-23
3105001437956810K230854SwiftMRLLZ2023-10-27
638791616534223K221203AHI SystemQNV2022-07-14
3105001422796129K220416SwiftMRLLZ2022-05-25
638791065300707K212219AHI SystemQNV2021-12-03
638791043142467K211949AirStrip ONE Web Client with Alarm Communication Management (ACM)MSX2021-12-09
3105001975243946K210999SwiftMRLLZ2021-10-14
638791992348465K160862AirStrip RPMMSX2016-09-19
638791901877138K142106DECISIO HEALTH PATIENT DASHBOARDMWI2015-01-18
638791734020733K133450AIRSTRIP REMOTE PATIENT MONITORINGMWI2014-02-14
638791886953055K112235AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGMWI2011-08-26
310311640404332K101154CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-LCAW2011-03-28
638791645273910K090269AIRSTRIP OBHGM2009-02-13
638791995983979DEN200022Analytic for Hemodynamic Instability (AHI)QNV2021-03-01
192971653923470
310311783091289

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ32023-10-27
QNV32022-07-14
MWI32015-01-18
QIH22026-03-26
MSX22021-12-09
JPK21999-06-17
GIO21988-12-01
CAW12011-03-28
HGM12009-02-13

NDC#

PMN#

SwiftMR

2023-10-27

Airs Medical, Inc.

GUDID#

SwiftMR - SwiftMR is a stand-alone medical imaging software solution intended for the acceptance, enhancement, processing, review, analysis, communication, and transfer of all body parts MR images in DICOM format. The software may be used for the enhancement of medical images, such as noise reduction and increased image sharpness for MR images.The device is designed for use by healthcare professionals and is intended to assist clinicians, who remain responsible for making all final patient management decisions. The device is not intended for use on mobile devices.The available field strengths are as follows: 0.25T, 0.31T, 0.4T, 0.55T, 0.6T, 1.5T, and 3.0T.

AIRS Medical Inc.

2026-04-01

Airsonett AIR-4 - Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett and passes a filter that captures allergens and other particles. The filtered air is cooled to slightly below the ambient room temperature and is supplied with a low velocity from the air supply nozzle. Since the filtered air is slightly cooler, and therefore heavier than the surrounding air, the filtered air will descend slowly from the air supply nozzle by means of gravity in a laminar manner (non-turbulent). This descending colder air counteracts the body convection, displaces the allergen load in the breathing zone and thus dramatically reduces the level of inhalant allergens for the patient all through the night.

Airsonett AB

2023-02-01

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